—#202914

Product

MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument

FDA product code: NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K153745
Affected lot / code info: UDI/DI 10193489189759 (each), 20888277680446 (case), Lot Numbers: 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, 499343

Why it was recalled

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

Root cause (FDA determination)

Packaging

Action the firm took

Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-08-03
Posted by FDA: 2023-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202914. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.